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PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer

BMC cancer, 2015-08, Vol.15 (1), p.602, Article 602 [Peer Reviewed Journal]

COPYRIGHT 2015 BioMed Central Ltd. ;COPYRIGHT 2015 BioMed Central Ltd. ;Copyright BioMed Central 2015 ;Owadally et al. 2015 ;ISSN: 1471-2407 ;EISSN: 1471-2407 ;DOI: 10.1186/s12885-015-1598-x ;PMID: 26311526

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Title:
PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer
Author: Owadally, Waheeda ; Hurt, Chris ; Timmins, Hayley ; Parsons, Emma ; Townsend, Sarah ; Patterson, Joanne ; Hutcheson, Katherine ; Powell, Ned ; Beasley, Matthew ; Palaniappan, Nachi ; Robinson, Max ; Jones, Terence M ; Evans, Mererid
Subjects: Care and treatment ; Chemoradiotherapy, Adjuvant - methods ; Complications and side effects ; Deglutition - radiation effects ; Deglutition disorders ; Health aspects ; Humans ; Medical research ; Medicine, Experimental ; Neck Dissection - methods ; Oral Surgical Procedures - methods ; Oropharyngeal Neoplasms - pathology ; Oropharyngeal Neoplasms - therapy ; Oropharyngeal Neoplasms - virology ; Papillomavirus Infections - pathology ; Papillomavirus Infections - therapy ; Prognosis ; Prospective Studies ; Quality of Life ; Radiation Dosage ; Radiotherapy, Adjuvant - methods ; Risk factors ; Study Protocol ; Survival Analysis ; Treatment Outcome
Is Part Of: BMC cancer, 2015-08, Vol.15 (1), p.602, Article 602
Description: Human papillomavirus-positive oropharyngeal squamous cell carcinoma is increasing in incidence worldwide. Current treatments are associated with high survival rates but often result in significant long-term toxicities. In particular, long-term dysphagia has a negative impact on patient quality of life and health. The aim of PATHOS is to determine whether reducing the intensity of adjuvant treatment after minimally invasive transoral surgery in this favourable prognosis disease will result in better long-term swallowing function whilst maintaining excellent disease-specific survival outcomes. The study is a multicentre phase II/III randomised controlled trial for patients with biopsy-proven Human papillomavirus-positive oropharyngeal squamous cell cancer staged T1-T3 N0-N2b with a primary tumour that is resectable via a transoral approach. Following transoral surgery and neck dissection, patients are allocated into three groups based on pathological risk factors for recurrence. Patients in the low-risk pathology group will receive no adjuvant treatment, as in standard practice. Patients in the intermediate-risk pathology group will be randomised to receive either standard dose post-operative radiotherapy (control) or reduced dose radiotherapy. Patients in the high-risk pathology group will be randomised to receive either post-operative chemoradiotherapy (control) or radiotherapy alone. The primary outcome of the phase II study is patient reported swallowing function measured using the MD Anderson Dysphagia Inventory score at 12 months post-treatment. If the phase II study is successful, PATHOS will proceed to a phase III non-inferiority trial with overall survival as the primary endpoint. PATHOS is a prospective, randomised trial for Human papillomavirus-positive oropharyngeal cancer, which represents a different disease entity compared with other head and neck cancers. The trial aims to demonstrate that long-term dysphagia can be lessened by reducing the intensity of adjuvant treatment without having a negative impact on clinical outcome. The study will standardise transoral surgery and post-operative intensity-modulated radiotherapy protocols in the UK and develop a gold-standard swallowing assessment panel. An associated planned translational research programme, underpinned by tumour specimens and sequential blood collected as part of PATHOS, will facilitate further empirical understanding of this new disease and its response to treatment. This study is registered with ClinicalTrials.gov identifier NCT02215265 .
Publisher: England: BioMed Central Ltd
Language: English
Identifier: ISSN: 1471-2407
EISSN: 1471-2407
DOI: 10.1186/s12885-015-1598-x
PMID: 26311526
Source: GFMER Free Medical Journals
MEDLINE
PubMed Central
Springer Nature OA/Free Journals
ROAD: Directory of Open Access Scholarly Resources
ProQuest Central
DOAJ Directory of Open Access Journals

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PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer

COPYRIGHT 2015 BioMed Central Ltd. ;COPYRIGHT 2015 BioMed Central Ltd. ;Copyright BioMed Central 2015 ;Owadally et al. 2015 ;ISSN: 1471-2407 ;EISSN: 1471-2407 ;DOI: 10.1186/s12885-015-1598-x ;PMID: 26311526

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